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Evaluation of a Parent-Infant Interaction Model

Evaluation of a Parent-Infant Interaction Model in the Neonatal Intensive Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02034617
Acronym
LiMoNid
Enrollment
140
Registered
2014-01-13
Start date
2014-01-01
Completion date
2024-05-31
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

Cognition, Family nursing, Infant, premature, Object attachment, Stress, physiological, Stress, psychological

Brief summary

When becoming a parent of a preterm infant there is an increased risk of stress. There are a number of studies showing that parental stress has a negative impact on their engagement with their child. Other studies, on the other hand, show that different intervention programs with the aim to strengthen the relationship can decrease parental stress and hence affect the parent-infant interaction in a positive way. Structured intervention programs for preterm infants have also been successful in improving the infants' cognitive functions. The investigators have developed a program with the aim to strengthen the parent-infant interaction for late preterm infants. The observational program is called LiMoNid. Our hypothesis is that LiMoNid will strengthen the parents' own parental abilities and give them a deeper understanding of their child. They will hopefully develop more skills on how to communicate with their child; to see, interpret, understand and approach the child, which can lead to an improved parent-child interaction. Parental stress may also be reduced by increased understanding and control. Regarding the child itself, we hypothesize that the psychological development will be affected depending on the communication with the caregiver and depending on the support it has received in expressing its feelings and needs. The emotional regulation should be strengthened by such an intervention. The aim is to study if LiMoNid can have an impact on cognition, stress, parent-child interaction.

Detailed description

The Design is a randomised controlled study in two groups; intervention group versus standard care. Parents who meet the inclusion criteria are given oral and written information about the study aim and procedure and are asked for participation. If the parents consent they will be randomised to one of two groups. Follow-ups will be conducted at 1 month, 4 months, 10-12 months corrected age and when the child is 4 years.

Interventions

BEHAVIORALLiMoNid

One LiMoNid observation will be performed on day 1-3 post birth, one in time of discharge, and one in the home when the infant has reached 40 weeks (+/- 2 week). All observations are performed in presence of and in collaboration with the parents with the outspoken aim to guide the parents to learn how to read and respond to their infant' signals

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 96 Hours
Healthy volunteers
No

Inclusion criteria

* Preterm infants born 30-36 weeks gestational age without known major malformations or complications * Families living in the county of Ostergotland, Sweden * Swedish speaking parents * Single or duplex birth

Exclusion criteria

* Complications encountered during hospital stay that are known to affect cognition

Design outcomes

Primary

MeasureTime frameDescription
Cognitive abilities11 monthsBayley Scales of Infant Development

Secondary

MeasureTime frameDescription
Stress reactivity1 monthSalivary cortisol reactivity in relation to bath

Other

MeasureTime frameDescription
Parental stress1 monthEdinburgh Post Depression Scale (EPDS) and State-Trait and Anxiety Inventory, short version (STAI)
Emotions11 monthsAges and Stages Questionnaire: Social and emotional (ASQ-SE)
Parent-child interaction1 monthAinsworth sensitivity scale
Parental style4 yearsParenting Scale (PS)
Cognitive abilities4 yearsWechsler Preschool and Primary Scale of Intelligence (WPPSI-III)
Stress reactivity4 monthsSalivary cortisol reactivity in relation to still-face

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026